Application of traditional Chinese medicine composition in preparation of medicine for treating acute upper respiratory infection caused by bacteria

Abstract

The invention discloses application of a traditional Chinese medicine composition in preparation of a medicine for treating acute upper respiratory infection caused by bacteria, the traditional Chinese medicine composition comprises the following traditional Chinese medicine raw materials in parts by weight: 5-35 parts of bupleurum chinense, 9-50 parts of scutellaria baicalensis, 9-50 parts of artemisia apiacea, 5-35 parts of radix paeoniae rubra, 5-35 parts of moutan bark and 4-26 parts of folia perillae acutae. The traditional Chinese medicine composition is used for treating the acute upper respiratory tract infection caused by bacteria, such as heavy body heat, slight aversion to wind, unsmooth sweating, dry throat or red, swollen and painful throat, nasal obstruction, yellow and turbid nasal discharge, cough, sticky or yellow phlegm, thirst to drink, head swelling pain and tonsil enlargement, so that the acute upper respiratory tract infection can be effectively treated.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, specifically relating to the application of a traditional Chinese medicine composition in the preparation of a drug for treating acute upper respiratory tract infections caused by bacteria. Background Technology

[0002] Acute upper respiratory tract infection (ALI) is a general term for acute inflammation of the respiratory mucosa, including the nasal cavity, pharynx, and larynx, extending from the external nasal nostrils to the cricoid cartilage. Most are viral infections, with a small percentage being bacterial. Broadly speaking, it includes the common cold, acute viral pharyngitis and laryngitis, acute pharyngoconjunctivitis, and acute tonsillitis. Etiologically, ATIs are often triggered by factors such as fatigue, exposure to rain, and chills, leading to a weakened immune system and the invasion or reproduction of external pathogens or pathogens carried in the respiratory tract. From a Traditional Chinese Medicine (TCM) perspective, it is caused by external wind-evil, internal heat accumulation, and impaired lung function. It primarily affects the lung and wei qi, but can also involve the shao yang, spleen, and stomach in the middle jiao.

[0003] From the perspective of traditional Chinese medicine, upper respiratory tract infection is caused by the invasion of the body by the six pathogenic factors:

[0004] 1. Among the six pathogenic factors, wind often takes precedence: wind combined with cold is called wind-cold syndrome, wind combined with heat is called wind-heat syndrome, and summer heat often accompanied by dampness is called wind-summer-dampness syndrome.

[0005] 2. Caused by wind-heat evil, heat stagnation in the muscles and skin, disharmony of the defensive qi, and failure of the lungs to clear and purify.

[0006] 3. Pathogenic factors are an important factor in upper respiratory tract diseases.

[0007] Traditional Chinese medicine believes that wind, as the primary pathogenic factor, invades the body through the mouth and nose or through the skin and hair. Because wind is light and airy, the *Suwen* (Plain Questions) states, "Those injured by wind are first affected in the upper body." The lungs, being the highest of the internal organs, open to the nose, are responsible for respiration, and govern the skin and hair. They are delicate and susceptible to pathogenic invasion. Therefore, when external pathogens invade through the mouth, nose, skin, and hair, the lungs and their defensive qi are the first to be affected. Disharmony between the lungs and their defensive qi manifests as chills, fever, and headache. Impaired lung function leads to nasal congestion, runny nose, itchy throat, and sore throat.

[0008] When wind-heat attacks the exterior, heat stagnates in the muscles and skin, and the defensive qi is disrupted, resulting in a slight fever, aversion to wind, and difficulty in sweating. When wind-heat disturbs the upper body, it causes headache and distending pain. When wind-heat evil steams the clear passages, it causes sore throat, dry throat, thirst, and runny nose with thick nasal discharge. When wind-heat attacks the lungs, the lungs lose their ability to clear and purify, resulting in cough and sticky yellow phlegm.

[0009] Traditional Chinese Medicine (TCM) etiology and mechanism: The pathological changes are due to insufficient vital energy (Qi), weakened defensive function, and lax regulation of the lung and wei qi, allowing the six pathogenic factors (wind, cold, heat, dampness, dryness, fire, and fire) to invade. These pathogenic factors enter through the mouth, nose, skin, and hair, with the lung and wei qi bearing the brunt, quickly leading to disharmony of the defensive qi and impaired lung function. It may also be caused by improper lifestyle, imbalance of cold and heat, or overwork, resulting in weakened muscle defense and invasion of external pathogens.

[0010] The Western medical etiology of upper respiratory tract infections is as follows: weakened immune function and physiological structure are the internal conditions, while the virulence of the pathogen is the external condition leading to the onset of the disease. After the pathogen invades the respiratory tract, it multiplies locally, directly damaging the respiratory organs or releasing toxic substances. The body, due to the invasion of the pathogen, damages and induces immune responses and cytokines, leading to pathological processes.

[0011] Traditional Chinese medicine emphasizes syndrome differentiation and treatment, adhering to the principle that "prescriptions are derived from treatment methods, and treatment methods are established according to syndromes." Different combinations of prescriptions, based on their own treatment principles, have different principal, assistant, adjuvant, and guide ingredients, and target different pathologies and mechanisms, resulting in significant differences.

[0012] Based on clinical practice, current treatments for upper respiratory tract infections target symptoms such as fever, cough, nasal congestion, dry throat, and sore throat. Clinical treatment with Western medicine includes antipyretics and antibiotics. However, the overuse of antibiotics, frequent changes in antibiotics, and the use of broad-spectrum antibiotics often suppress and kill normal flora, leading to fungal infections, increasing drug-resistant bacteria and hospital-acquired infections, causing weakened immunity, and worsening the condition. Because wind-heat pathogens easily damage body fluids, medication should only induce a slight sweat; excessive sweating can further damage body fluids, leading to complications and worsening the condition.

[0013] However, the use of Western antipyretics and analgesics, especially steroid antipyretics, can lead to excessive sweating and depletion of body fluids. This formula induces mild sweating, mitigating the shortcomings of Western medications. Therefore, rational drug use is of great significance in alleviating the clinical symptoms of patients with stagnation.

[0014] The composition of this invention combines the inheritance of traditional Chinese medicine theory with innovation supported by modern scientific and technological evidence. It is also supported by modern pharmacodynamic experimental data and verified by clinical applications. It cannot be easily obtained through conventional additions or subtractions of medicinal ingredients. Summary of the Invention

[0015] The technical problem to be solved by the present invention is to provide an application of a traditional Chinese medicine composition in the preparation of a drug for treating acute upper respiratory tract infections caused by bacteria.

[0016] Traditional Chinese medicine has advantages in treating upper respiratory tract infections. This invention applies clinical practice and traditional Chinese medicine theory to develop a Chinese medicine antibacterial treatment method for upper respiratory tract infections.

[0017] Based on the clinical symptoms of upper respiratory tract infection, the clinical application of this invention is positioned as an application for wind-heat symptoms: high fever, slight aversion to wind, poor sweating, dry throat or sore throat with redness and swelling, nasal congestion, yellow and turbid nasal discharge, cough with sticky or yellow phlegm, thirst, headache, and enlarged tonsils.

[0018] Based on the analysis of the clinical characteristics of acute upper respiratory tract infections, combined with traditional Chinese medicine theory and the characteristics of this invention patent, the clinical application is more precisely targeted at acute upper respiratory tract infections (wind-heat type) and tonsillitis, making it more clinically valuable.

[0019] In this formula, Scutellaria baicalensis and Artemisia annua are the principal herbs. Scutellaria baicalensis, bitter and cold in nature, enters the lung, gallbladder, and stomach meridians. The *Compendium of Materia Medica* states that it "treats phlegm-heat, benefits the chest and diaphragm, and treats pulmonary atrophy with cough and bloody pus." Zhang Yuansu's *Medical Origins* states that "Scutellaria baicalensis clears lung heat and treats damp-heat in the upper burner." Modern research shows that its active ingredient, baicalin, can significantly inhibit the activity of influenza virus neuraminidase (Wang Jinhua et al., 2015, *Chinese Journal of Traditional Chinese Medicine*). Artemisia annua, bitter and pungent in nature, is cold in nature. The *Essentials of Materia Medica* states that it "treats malaria with phlegm-cough, deficiency-heat, and night sweats." The Artemisia annua and turtle shell decoction in *Treatise on Febrile Diseases* uses Artemisia annua to expel heat. Its antiviral mechanism aligns with Wu Youke's treatment principle in *Treatise on Epidemic Febrile Diseases*, which emphasizes "expelling pathogens as the primary principle."

[0020] Bupleurum, Paeonia lactiflora, and Paeonia suffruticosa are the assistant herbs. Bupleurum is listed as a superior herb in the *Shennong Bencao Jing* (Shennong's Classic of Materia Medica), "treating stagnation of qi in the heart, abdomen, intestines, and stomach, food accumulation, and cold and heat evil qi." Its combination with Scutellaria baicalensis follows the principle of "harmonizing the lesser yang" in the *Shanghan Lun* (Treatise on Cold Damage), as Ke Qin stated: "Bupleurum soothes the wood element, Scutellaria baicalensis clears the metal element; this is a key remedy for the lesser yang" (*Shanghan Laisu Ji*). Paeonia lactiflora, according to *Yaopin Huayi* (Medical Properties Explained), "drains liver fire, eliminates blood stasis, and disperses stagnant blood." Combined with Bupleurum, it subtly aligns with Wang Qingren's Xuefu Zhuyu Tang (Blood-Stasis-Expelling Decoction) method of "regulating both qi and blood" (*Yilin Gaicuo*). Modern research confirms that its paeoniflorin can downregulate influenza virus-induced TNF-α overexpression (Li Chun et al., 2018, *Chinese Journal of Experimental Traditional Medical Formulae*). Paeonia suffruticosa, according to *Benjing Shuzheng* (Commentary on the Classic of Materia Medica), "treats cold and heat stroke, convulsions and epilepsy." Zhang Zhongjing's Shenqi Wan (Kidney Qi Pill) uses Paeonia suffruticosa to clear deficiency heat. This formula utilizes the property of "entering the blood and purging latent fire" (Zhang Xichun's "Medical Records of Integrating Chinese and Western Medicine") to prevent heat toxins from invading the blood.

[0021] Perilla leaf is used as an adjuvant herb. The *Compendium of Materia Medica* states that it "disperses cold qi, clears lung qi, and soothes the middle qi." This formula utilizes its three effects: ① As an adjuvant: preventing the bitter and cold herbs Scutellaria baicalensis and Artemisia annua from harming the stomach, reflecting the principle of "no harm if there is a cause" in the *Inner Canon of Medicine*; ② Guiding the medicine: its pungent and aromatic nature allows it to reach the exterior, guiding the medicine to the lung and wei levels, as Xu Lingtai stated: "All light and weak medicines can enter the lungs" (*On the Origin and Development of Medicine*); ③ Harmonizing the stomach: addressing the common "lung and stomach disease" symptoms of influenza, practicing Ye Tianshi's academic thought of "treating the middle to treat the upper disease."

[0022] In summary, this formula is based on the theory of febrile diseases and the differentiation of syndromes based on Wei Qi Ying Xue. It targets the core pathogenesis of influenza, which is "wind-heat epidemic toxin attacking the exterior and internally affecting the lungs and stomach." It takes Ye Tianshi's "sweating is acceptable when it is in the Wei stage, but clearing the Qi is necessary when it reaches the Qi stage" (Treatise on Febrile Diseases) as the treatment guideline, and integrates Wu Jutong's medicine-using philosophy of "treating the upper Jiao is like lifting a feather, it cannot be done without lightness" (Treatise on Febrile Diseases). The combined use of various medicines achieves the effects of clearing heat and detoxifying, and expelling pathogens from the exterior.

[0023] This invention is based on traditional Chinese medicine theory and follows traditional Chinese medicine theory and practice.

[0024] 1. Clinically speaking, the main symptom of acute upper respiratory tract infection (wind-heat type) and tonsillitis is fever. The main combination of herbs is Artemisia annua, Scutellaria baicalensis and Bupleurum chinense, which have heat-clearing and antibacterial properties.

[0025] 2. From the perspective of differentiation of syndromes based on Wei Qi Ying Xue: Heat evil and pathogenic factors permeate the Qi level, Ying level, and Ying Xue level. Clearing heat in the Qi level, Ying level, and Xue level simultaneously is crucial. Heat evil and pathogenic factors first affect the lungs, spreading from the interior to the exterior. Use peony bark and red peony root to clear heat, cool the blood, detoxify, and clear heat in the Ying and Xue levels. Interrupt the development of the febrile disease, prevent its progression, and avoid worsening of the condition.

[0026] 3. Observing the Ascending, Descending, Entering, and Exiting of Qi in Pathogenic Factors in the Lesser Yang: The *Suwen* states, "Ascending, descending, entering, and exiting exist in all things." The pivot is like the axis of a doorway, functioning through the ascending, descending, entering, and exiting of Qi. The key to regulating Qi lies in the pivot, especially the pivot of the Lesser Yang. The Lesser Yang relies on the pivot for its function, indicating its important role in regulating the flow of Qi between the interior and exterior, and ensuring smooth Qi circulation. When pathogenic factors invade the Lesser Yang, the Qi circulation in the Lesser Yang becomes obstructed, leading to stagnation and the transformation of heat and fire. The treatment approach starts with the Lesser Yang: Artemisia annua, Scutellaria baicalensis, and Bupleurum chinense, which disperse, clear, moisten, and dredge the Lesser Yang.

[0027] 4. Based on clinical practice and TCM syndrome differentiation: The combination of wind-heat attacking the exterior and wind-heat attacking the defensive qi is clinically positioned as wind-heat type.

[0028] Modern scientific research, with its effective material basis, also confirms the scientific validity of the application of this invention patent.

[0029] The antibacterial effects of each medicinal ingredient in the composition used in this patented invention:

[0030] 1. Bupleurum chinense

[0031] Active ingredients: Saikosaponins a,b,c,d, volatile oils (β-pinene, limonene). Reported antibacterial effects: Staphylococcus aureus: inhibits bacterial biofilm formation (MIC: 250-500 μg / mL); Staphylococcus epidermidis: disrupts cell membrane integrity; Propionibacterium acnes: reduces the expression of the inflammatory factor TNF-α.

[0032] 2. Scutellaria baicalensis

[0033] Active ingredients: Baicalin, Wogonoside, Baicalein. Their antibacterial effects have been reported as follows: MRSA (methicillin-resistant Staphylococcus aureus): inhibits β-lactamase activity (MIC: 32-64 μg / mL); Escherichia coli: disrupts outer membrane protein OmpF; Candida albicans: inhibits hyphal transformation.

[0034] 3. Red peony (Paeonia lactiflora)

[0035] Active ingredients: Paeoniflorin, gallic acid, and oxypaeoniflorin. Their antibacterial effects have been reported as follows: Pseudomonas aeruginosa: inhibits the quorum sensing system (LasI / RhlI); Group beta-hemolytic streptococci: blocks the release of hemolysin O; Helicobacter pylori: inhibits urease activity.

[0036] 4. Peony bark (Paeonia suffruticosa)

[0037] Active ingredients: Paeonol, Paeoniflorin, Galloylpaeoniflorin. Their antibacterial effects have been reported as follows: Candida albicans: inhibits the ERG11 gene (reducing ergosterol synthesis); Propionibacterium acnes: reduces TLR2 / NF-κB pathway activation; Shigella flexneri: inhibits type III secretory system effector proteins.

[0038] 5. Artemisia annua

[0039] Active ingredients: Artemisinin, Artesunate, volatile oils (camphor, eucalyptol). Reported antibacterial effects: Mycobacterium tuberculosis: enhances macrophage ROS killing (MIC: 4 μg / mL); Plasmodium falciparum: iron-mediated free radical damage (anti-parasite); Leishmania: induces mitochondrial membrane potential collapse.

[0040] 6. Perilla (Perilla frutescens)

[0041] Active ingredients: Perillaldehyde, Rosmarinic acid, Luteolin. Their antibacterial effects have been reported as follows: Listeria monocytogenes: disrupts cell membrane potential (MIC: 0.2 μL / mL); Salmonella: inhibits type III flagellin secretion; Aspergillus flavus: inhibits aflatoxin B1 synthesis.

[0042] The compositions of this invention have achieved good clinical and experimental results in clinical applications and modern pharmacodynamic studies.

[0043] To address the aforementioned technical problems, this invention provides the application of a traditional Chinese medicine composition in the preparation of a drug for treating acute upper respiratory tract infections caused by bacteria. The weight ratio of the various components is as follows: Bupleurum chinense 5-35 parts, Scutellaria baicalensis 9-50 parts, Artemisia annua 9-50 parts, Paeonia lactiflora 5-35 parts, Paeonia suffruticosa 5-35 parts, and Perilla frutescens 4-26 parts.

[0044] In the aforementioned traditional Chinese medicine composition, the preferred weight ratio of each component is as follows: Bupleurum chinense 8-28 parts, Scutellaria baicalensis 12-40 parts, Artemisia annua 12-40 parts, Paeonia lactiflora 8-28 parts, Paeonia suffruticosa 8-28 parts, and Perilla frutescens 8-22 parts.

[0045] In the aforementioned traditional Chinese medicine composition, the preferred weight ratio of each component is as follows: Bupleurum chinense 10-25 parts, Scutellaria baicalensis 20-35 parts, Artemisia annua 20-35 parts, Paeonia lactiflora 10-25 parts, Paeonia suffruticosa 10-25 parts, and Perilla frutescens 12-20 parts.

[0046] The aforementioned traditional Chinese medicine composition can be prepared into any commonly used formulation.

[0047] The traditional Chinese medicine composition can be used to prepare preparations including tablets, capsules, granules, pills, mixtures, syrups, decoctions, powders, suppositories, gels, sprays, or injections.

[0048] The Chinese medicines described in this invention can be replaced by Chinese medicines with the same or similar effects, and these medicinal materials can all be processed in accordance with the "National Standards for Processing Chinese Medicines" or the "Dictionary of Chinese Materia Medica". For example, Scutellaria baicalensis can be replaced by Scutellaria baicalensis processed with wine, Bupleurum chinense can be replaced by Bupleurum chinense, and Paeonia lactiflora can be replaced by Paeonia veitchii. The efficacy of the replaced medicinal materials can be better than that of the original medicinal materials, but all of them are within the scope of this invention.

[0049] To address the aforementioned technical problems, this invention provides the application of a traditional Chinese medicine composition in the preparation of a drug for treating acute upper respiratory tract infections caused by bacteria. The preparation method includes the following steps:

[0050] ① Weigh out the following raw materials according to the proportions: 5-35 parts of Bupleurum chinense, 9-50 parts of Scutellaria baicalensis, 9-50 parts of Artemisia annua, 5-35 parts of Paeonia lactiflora, 5-35 parts of Paeonia suffruticosa, and 4-26 parts of Perilla frutescens.

[0051] ② Take Bupleurum chinense, Scutellaria baicalensis, Artemisia annua, Paeonia lactiflora, Paeonia suffruticosa, and Perilla frutescens leaves, add 6 to 14 times the amount of raw herbs to water, heat and reflux for 0.5 to 5 hours, heat and reflux for 1 to 3 times, filter, combine the extracts, and concentrate under reduced pressure at 40 to 90℃ to a density of 1.01 to 1.20 for later use;

[0052] ③Dry the concentrated liquid from step ② at 50-90℃, pulverize the dried paste, add excipients, and prepare the formulation.

[0053] To address the aforementioned technical problems, the present invention provides a method for preparing a traditional Chinese medicine composition, the method comprising the following steps:

[0054] ① Weigh out the following raw materials according to the proportions: 5-35 parts of Bupleurum chinense, 9-50 parts of Scutellaria baicalensis, 9-50 parts of Artemisia annua, 5-35 parts of Paeonia lactiflora, 5-35 parts of Paeonia suffruticosa, and 4-26 parts of Perilla frutescens.

[0055] ② Take Bupleurum chinense, Scutellaria baicalensis, and Artemisia annua, add 6 to 14 times the amount of water or ethanol, heat and reflux for 0.5 to 5 hours, heat and reflux for 1 to 3 times, filter, combine the extracts, and concentrate under reduced pressure at 40 to 90℃ to a density of 1.01 to 1.20 for later use;

[0056] ③ Take peony bark, red peony root, and perilla leaf, add 6-14 times the amount of raw herbs to 50%-90% ethanol or water, heat and reflux for 0.5-5 hours, heat and reflux for 1-3 times, filter, combine the extracts, concentrate under reduced pressure at 40-90℃ to a density of 1.01-1.20, combine the concentrate from step ②, and continue to concentrate to a density of 1.05-1.15, for later use;

[0057] ④ Dry the concentrated liquid from step ③ at 50–90°C, pulverize the dried paste, add excipients, and prepare the formulation.

[0058] To address the aforementioned technical problems, the present invention also provides a method for preparing a traditional Chinese medicine composition, the method comprising the following steps:

[0059] ① Weigh out the following raw materials according to the proportions: 5-35 parts of Bupleurum chinense, 9-50 parts of Scutellaria baicalensis, 9-50 parts of Artemisia annua, 5-35 parts of Paeonia lactiflora, 5-35 parts of Paeonia suffruticosa, and 4-26 parts of Perilla frutescens.

[0060] ② Take Bupleurum chinense, Scutellaria baicalensis, Artemisia annua, Paeonia lactiflora, Paeonia suffruticosa, and Perilla frutescens leaves, add 6-12 times the amount of raw herbs to 50%-90% ethanol, heat and reflux for 1-3 hours, heat and reflux for 1-3 times, filter, combine the extracts, and concentrate under reduced pressure at 50-90℃ to a density of 1.05-1.20 for later use;

[0061] ③Dry the concentrated liquid from step ② at 50-90℃, pulverize the dried paste, add excipients, and prepare the formulation.

[0062] To address the aforementioned technical problems, the present invention also provides a method for preparing a traditional Chinese medicine composition, the method comprising the following steps:

[0063] ① Weigh out the following raw materials according to the proportions: 5-35 parts of Bupleurum chinense, 9-50 parts of Scutellaria baicalensis, 9-50 parts of Artemisia annua, 5-35 parts of Paeonia lactiflora, 5-35 parts of Paeonia suffruticosa, and 4-26 parts of Perilla frutescens.

[0064] ② Take Bupleurum chinense, Scutellaria baicalensis, and Paeonia lactiflora, grind them into powder, sift them to obtain medium powder, and set aside;

[0065] ③ Take peony bark, perilla leaf, and artemisia annua, add 6 to 14 times the amount of raw herbs to water, soak for 0.5 to 1 hour, heat and reflux for 1 to 3 hours, heat and reflux for 1 to 3 times, filter, combine the extracts, concentrate under reduced pressure at 50 to 90℃ to a density of 1.05 to 1.20, add the powder from step ②, stir evenly, and set aside.

[0066] ④ Dry the thick paste from step ③ at 50–90°C, pulverize the dried paste, add excipients, and prepare the formulation.

[0067] To address the aforementioned technical problems, the present invention also provides a method for preparing a traditional Chinese medicine composition, the method comprising the following steps:

[0068] ① Weigh out the following raw materials according to the proportions: 5-35 parts of Bupleurum chinense, 9-50 parts of Scutellaria baicalensis, 9-50 parts of Artemisia annua, 5-35 parts of Paeonia lactiflora, 5-35 parts of Paeonia suffruticosa, and 4-26 parts of Perilla frutescens.

[0069] ② Take Bupleurum chinense, Scutellaria baicalensis, Artemisia annua, Paeonia lactiflora, Paeonia suffruticosa, and Perilla frutescens leaves, grind them into powder, sift them, and set aside;

[0070] ③ Add the powder from step ② to the excipients to prepare the formulation. Attached Figure Description

[0071] Figure 1 This is a line graph comparing rectal temperature of the control drug in the antipyretic test with that of the composition of the present invention. Detailed Implementation

[0072] The following examples are used to illustrate the preparation of the drug of the present invention, but they should not be construed as limiting the scope of the present invention.

[0073] Example 1

[0074] The application of a traditional Chinese medicine composition in the preparation of a drug for treating acute upper respiratory tract infections caused by bacteria, wherein the raw materials, by weight, include 30 parts of Bupleurum chinense, 40 parts of Scutellaria baicalensis, 40 parts of Artemisia annua, 20 parts of Paeonia lactiflora, 20 parts of Paeonia suffruticosa, and 10 parts of Perilla frutescens.

[0075] Specific preparation steps:

[0076] ① Take Bupleurum chinense, Scutellaria baicalensis, and Artemisia annua, add 12 times the amount of raw herbs to water, reflux and extract for 2 hours, filter, and set aside the filtrate. Add 12 times the amount of raw herbs to 80% ethanol, reflux and extract for 2 hours, filter, combine the two extracts, and concentrate under reduced pressure at 60℃ to a density of 1.08, and set aside.

[0077] ② Take peony bark, red peony root, and perilla leaf, add 12 times the amount of raw herbs to 80% ethanol, reflux extract for 2 hours, filter, and set aside the filtrate. Add 12 times the amount of raw herbs to the residue, reflux extract for 2 hours, filter, combine the two extracts, concentrate under reduced pressure at 60℃ to a density of 1.08, combine the concentrate from step ①, and continue to concentrate to a density of 1.10, and set aside.

[0078] ③ The concentrate from step ② is dried at 70°C, the dried paste is pulverized and excipients are added to prepare capsules, thus obtaining the invention composition 1.

[0079] Example 2

[0080] The application of a traditional Chinese medicine composition in the preparation of a drug for treating acute upper respiratory tract infections caused by bacteria, wherein the raw materials, by weight, include 25 parts of Bupleurum chinense, 35 parts of Scutellaria baicalensis, 40 parts of Artemisia annua, 15 parts of Paeonia lactiflora, 15 parts of Paeonia suffruticosa, and 18 parts of Perilla frutescens.

[0081] Specific preparation steps:

[0082] ① Take Bupleurum chinense, Scutellaria baicalensis, and Artemisia annua, add 12 times the amount of raw herbs to water, reflux and extract for 2 hours, filter, and set aside the filtrate. Add 12 times the amount of raw herbs to 80% ethanol, reflux and extract for 2 hours, filter, combine the two extracts, and concentrate under reduced pressure at 60℃ to a density of 1.08, and set aside.

[0083] ② Take peony bark, red peony root, and perilla leaf, add 12 times the amount of raw herbs to 80% ethanol, reflux extract for 2 hours, filter, and set aside the filtrate. Add 12 times the amount of raw herbs to the residue, reflux extract for 2 hours, filter, combine the two extracts, concentrate under reduced pressure at 60℃ to a density of 1.08, combine the concentrate from step ①, and continue to concentrate to a density of 1.10, and set aside.

[0084] ③ The concentrate from step ② is dried at 70°C, the dried paste is pulverized and then excipients are added to prepare granules, thus obtaining the invention composition 2.

[0085] Example 3

[0086] The application of a traditional Chinese medicine composition in the preparation of a drug for treating acute upper respiratory tract infections caused by bacteria, wherein the raw materials, by weight, include 20 parts of Bupleurum chinense, 30 parts of Scutellaria baicalensis, 30 parts of Artemisia annua, 20 parts of Paeonia lactiflora, 20 parts of Paeonia suffruticosa, and 18 parts of Perilla frutescens.

[0087] Specific preparation steps:

[0088] ① Take Bupleurum chinense, Scutellaria baicalensis, Artemisia annua, Paeonia lactiflora, Paeonia suffruticosa, and Perilla frutescens leaves, add 12 times the amount of raw herbs to water, reflux and extract for 2 hours, filter, and set aside the filtrate. Add 12 times the amount of raw herbs to the residue, reflux and extract for 2 hours, filter, combine the two extracts, and concentrate under reduced pressure at 60℃ to a density of 1.08, and set aside.

[0089] ② The concentrate is dried at 60°C, the dried paste is pulverized and excipients are added to prepare capsules, thus obtaining the invention composition 3.

[0090] Example 4

[0091] The application of a traditional Chinese medicine composition in the preparation of a drug for treating acute upper respiratory tract infections caused by bacteria, wherein the raw materials, by weight, include 15 parts of Bupleurum chinense, 35 parts of Scutellaria baicalensis, 30 parts of Artemisia annua, 30 parts of Paeonia lactiflora, 20 parts of Paeonia suffruticosa, and 10 parts of Perilla frutescens.

[0092] Specific preparation steps:

[0093] ① Take Bupleurum chinense, Scutellaria baicalensis, Artemisia annua, Paeonia lactiflora, Paeonia suffruticosa, and Perilla frutescens leaves, add 12 times the amount of raw herbs to water, reflux and extract for 2 hours, filter, and set aside the filtrate. Add 12 times the amount of raw herbs to the residue, reflux and extract for 2 hours, filter, combine the two extracts, and concentrate under reduced pressure at 60℃ to a density of 1.08, and set aside.

[0094] ② The concentrate is dried at 60℃, the dried paste is pulverized and then excipients are added to prepare granules.

[0095] Example 5

[0096] The application of a traditional Chinese medicine composition in the preparation of a drug for treating acute upper respiratory tract infections caused by bacteria, wherein the raw materials, by weight, include 18 parts of Bupleurum chinense, 30 parts of Scutellaria baicalensis, 20 parts of Artemisia annua, 20 parts of Paeonia lactiflora, 30 parts of Paeonia suffruticosa, and 15 parts of Perilla frutescens.

[0097] Specific preparation steps:

[0098] ① Take Bupleurum chinense, Scutellaria baicalensis, and Artemisia annua, add 10 times the amount of raw herbs to 60% ethanol, reflux extract for 1.5 hours, filter, and set aside the filtrate. Add 10 times the amount of raw herbs to 60% ethanol, reflux extract for 1.5 hours, filter, combine the two extracts, and concentrate under reduced pressure at 60℃ to a density of 1.06, and set aside.

[0099] ② Take peony bark, red peony root, and perilla leaf, add 10 times the amount of raw herbs to water, reflux and extract for 1.5 hours, filter, and set aside the filtrate. Add 10 times the amount of raw herbs to the residue, reflux and extract for 1.5 hours, filter, combine the two extracts, and concentrate under reduced pressure at 70℃ to a density of 1.06. Combine the concentrate from step ① and continue to concentrate to a density of 1.09, and set aside.

[0100] ③Dry the concentrated liquid from step ② at 60℃, pulverize the dried paste, add excipients, and prepare capsules.

[0101] Example 6

[0102] The application of a traditional Chinese medicine composition in the preparation of a drug for treating acute upper respiratory tract infections caused by bacteria, wherein the raw materials, by weight, include 15 parts of Bupleurum chinense, 25 parts of Scutellaria baicalensis, 35 parts of Artemisia annua, 15 parts of Paeonia lactiflora, 20 parts of Paeonia suffruticosa, and 20 parts of Perilla frutescens.

[0103] Specific preparation steps:

[0104] ① Take Bupleurum chinense, Scutellaria baicalensis, and Artemisia annua, add 10 times the amount of raw herbs to 60% ethanol, reflux extract for 1.5 hours, filter, and set aside the filtrate. Add 10 times the amount of raw herbs to 60% ethanol, reflux extract for 1.5 hours, filter, combine the two extracts, and concentrate under reduced pressure at 60℃ to a density of 1.06, and set aside.

[0105] ② Take peony bark, red peony root, and perilla leaf, add 10 times the amount of raw herbs to water, reflux and extract for 1.5 hours, filter, and set aside the filtrate. Add 10 times the amount of raw herbs to the residue, reflux and extract for 1.5 hours, filter, combine the two extracts, and concentrate under reduced pressure at 70℃ to a density of 1.06. Combine the concentrate from step ① and continue to concentrate to a density of 1.09, and set aside.

[0106] ③Dry the concentrated liquid from step ② at 60℃, pulverize the dried paste, add excipients, and prepare granules.

[0107] Example 7

[0108] The application of a traditional Chinese medicine composition in the preparation of a drug for treating acute upper respiratory tract infections caused by bacteria, wherein the raw materials, by weight, include 30 parts of Bupleurum chinense, 30 parts of Scutellaria baicalensis, 30 parts of Artemisia annua, 25 parts of Paeonia lactiflora, 25 parts of Paeonia suffruticosa, and 15 parts of Perilla frutescens.

[0109] Specific preparation steps:

[0110] ① Take Bupleurum chinense, Scutellaria baicalensis, and Artemisia annua, add 10 times the amount of raw herbs to 50% ethanol, reflux extract for 1.5 hours, filter, and set aside the filtrate. Add 10 times the amount of raw herbs to 50% ethanol, reflux extract for 1 hour, filter, combine the two extracts, and concentrate under reduced pressure at 60℃ to a density of 1.05, and set aside.

[0111] ② Take peony bark, red peony root, and perilla leaf, add 10 times the amount of raw herbs to water, reflux and extract for 1.5 hours, filter, and set aside the filtrate. Add 10 times the amount of raw herbs to the residue, reflux and extract for 1 hour, filter, combine the two extracts, and concentrate under reduced pressure at 60℃ to a density of 1.04. Combine the concentrate from step ① and continue to concentrate to a density of 1.09, and set aside.

[0112] ③Dry the concentrated liquid from step ② at 60℃, pulverize the dried paste, add excipients, and prepare capsules.

[0113] Example 8

[0114] The application of a traditional Chinese medicine composition in the preparation of a drug for treating acute upper respiratory tract infections caused by bacteria, wherein the raw materials, by weight, include 20 parts of Bupleurum chinense, 30 parts of Scutellaria baicalensis, 30 parts of Artemisia annua, 20 parts of Paeonia lactiflora, 20 parts of Paeonia suffruticosa, and 15 parts of Perilla frutescens.

[0115] Specific preparation steps:

[0116] ① Take Bupleurum chinense, Scutellaria baicalensis, and Artemisia annua, add 10 times the amount of raw herbs to 70% ethanol, reflux extract for 1.5 hours, filter, and set aside the filtrate. Add 10 times the amount of raw herbs to 70% ethanol, reflux extract for 1 hour, filter, combine the two extracts, and concentrate under reduced pressure at 60℃ to a density of 1.05, and set aside.

[0117] ② Take peony bark, red peony root, and perilla leaf, add 10 times the amount of raw herbs to water, reflux and extract for 1.5 hours, filter, and set aside the filtrate. Add 10 times the amount of raw herbs to the residue, reflux and extract for 1 hour, filter, combine the two extracts, and concentrate under reduced pressure at 60℃ to a density of 1.04. Combine the concentrate from step ① and continue to concentrate to a density of 1.09, and set aside.

[0118] ③Dry the concentrated liquid from step ② at 60℃, pulverize the dried paste, add excipients, and prepare granules.

[0119] Example 9

[0120] The application of a traditional Chinese medicine composition in the preparation of a drug for treating acute upper respiratory tract infections caused by bacteria, wherein the raw materials, by weight, include 30 parts of Bupleurum chinense, 40 parts of Scutellaria baicalensis, 40 parts of Artemisia annua, 30 parts of Paeonia lactiflora, 30 parts of Paeonia suffruticosa, and 20 parts of Perilla frutescens.

[0121] Specific preparation steps:

[0122] ① Take Bupleurum chinense, Scutellaria baicalensis, Artemisia annua, Paeonia lactiflora, Paeonia suffruticosa, and Perilla frutescens leaves, add 10 times the amount of raw herbs to 80% ethanol, reflux extract for 1.5 hours, filter, and set aside the filtrate. Add 10 times the amount of raw herbs to the residue to 80% ethanol, reflux extract for 1.5 hours, filter, combine the two extracts, and concentrate under reduced pressure at 60℃ to a density of 1.10, and set aside.

[0123] ② The concentrated liquid from step ① is dried at 60℃, the dried paste is pulverized and excipients are added to prepare capsules.

[0124] Example 10

[0125] The application of a traditional Chinese medicine composition in the preparation of a drug for treating acute upper respiratory tract infections caused by bacteria, wherein the raw materials, by weight, include 32 parts of Bupleurum chinense, 48 parts of Scutellaria baicalensis, 45 parts of Artemisia annua, 28 parts of Paeonia lactiflora, 28 parts of Paeonia suffruticosa, and 18 parts of Perilla frutescens.

[0126] Specific preparation steps:

[0127] ① Take Bupleurum chinense, Scutellaria baicalensis, Artemisia annua, Paeonia lactiflora, Paeonia suffruticosa, and Perilla frutescens leaves, grind them into powder, sift them, and set aside;

[0128] ② Add the powder from step ① to excipients to prepare capsules.

[0129] Example 11

[0130] The application of a traditional Chinese medicine composition in the preparation of a drug for treating acute upper respiratory tract infections caused by bacteria, wherein the raw materials, by weight, include 20 parts of Bupleurum chinense, 30 parts of Scutellaria baicalensis, 40 parts of Artemisia annua, 15 parts of Paeonia lactiflora, 18 parts of Paeonia suffruticosa, and 12 parts of Perilla frutescens.

[0131] Specific preparation steps:

[0132] ① Take Bupleurum chinense, Scutellaria baicalensis, and Paeonia lactiflora, grind them into powder, sift them to obtain medium powder, and set aside;

[0133] ② Take peony bark, perilla leaf, and artemisia annua, add 6-14 times the amount of raw herbs to water, soak for 0.5-1 hour, heat and reflux for 1-3 hours, heat and reflux for 1-3 times, filter, combine the extracts, concentrate under reduced pressure at 50-90℃ to a density of 1.05-1.20, add the powder from step ①, stir evenly, and set aside.

[0134] ③Dry the thick paste from step ② at 60℃, pulverize the dried paste, add excipients, and prepare granules.

[0135] Comparative Example 1

[0136] The traditional Chinese medicine composition comprises, by weight, 30 parts of Bupleurum chinense, 40 parts of Scutellaria baicalensis, 40 parts of Artemisia annua, 40 parts of Isatis tinctoria, 30 parts of Pueraria lobata, 30 parts of Paeonia lactiflora, 30 parts of Paeonia suffruticosa, 20 parts of Ligusticum chuanxiong, and 20 parts of Perilla frutescens.

[0137] Specific preparation steps:

[0138] ① Take Bupleurum chinense, Scutellaria baicalensis, Artemisia annua, Isatis tinctoria, and Ligusticum chuanxiong. Add 10 times the amount of raw herbs in 70% ethanol and reflux for 1.5 hours. Filter and set aside the filtrate. Add 10 times the amount of raw herbs in 70% ethanol to the residue and reflux for 1 hour. Filter and combine the two extracts. Concentrate under reduced pressure at 60℃ to a density of 1.05 and set aside.

[0139] ② Take kudzu root, peony bark, red peony root, and perilla leaf, add 10 times the amount of raw herbs to water, reflux and extract for 1.5 hours, filter, and set aside the filtrate. Add 10 times the amount of raw herbs to the residue, reflux and extract for 1 hour, filter, combine the two extracts, and concentrate under reduced pressure at 60℃ to a density of 1.04. Combine the concentrate from step ① and continue to concentrate to a density of 1.09, and set aside.

[0140] ③ The concentrate from step ② is dried at 60°C, the dried paste is pulverized and then excipients are added to prepare granules, thus obtaining comparative composition 1.

[0141] Comparative Example 2

[0142] The traditional Chinese medicine composition comprises, by weight, 40 parts of Scutellaria baicalensis, 40 parts of Artemisia annua, 30 parts of Paeonia suffruticosa, and 20 parts of Perilla frutescens.

[0143] Specific preparation steps:

[0144] ① Take Scutellaria baicalensis and Artemisia annua, add 10 times the amount of raw herbs in 70% ethanol, reflux extract for 1.5 hours, filter, and set aside the filtrate. Add 10 times the amount of raw herbs in 70% ethanol to the residue, reflux extract for 1 hour, filter, combine the two extracts, and concentrate under reduced pressure at 60℃ to a density of 1.05, and set aside.

[0145] ② Take peony bark and perilla leaves, add 10 times the amount of raw herbs to water, reflux and extract for 1.5 hours, filter, and set aside the filtrate. Add 10 times the amount of raw herbs to the residue, reflux and extract for 1 hour, filter, combine the two extracts, concentrate under reduced pressure at 60℃ to a density of 1.04, combine the concentrate from step ①, and continue to concentrate to a density of 1.09, and set aside.

[0146] ③ The concentrate from step ② is dried at 60°C, the dried paste is pulverized and then excipients are added to prepare granules, thus obtaining comparative composition 2.

[0147] Comparative Example 3

[0148] The traditional Chinese medicine composition comprises, by weight, 30 parts of Bupleurum chinense, 40 parts of Scutellaria baicalensis, 40 parts of Isatis indigotica, 30 parts of Pueraria lobata, 30 parts of Paeonia lactiflora, 30 parts of Paeonia suffruticosa, 20 parts of Ligusticum chuanxiong, and 20 parts of Perilla frutescens.

[0149] Specific preparation steps:

[0150] ① Take Bupleurum chinense, Scutellaria baicalensis, Isatis indigotica, and Ligusticum chuanxiong, add 10 times the amount of raw herbs in 70% ethanol, reflux extract for 1.5 hours, filter, and set aside the filtrate. Add 10 times the amount of raw herbs in 70% ethanol to the residue, reflux extract for 1 hour, filter, combine the two extracts, and concentrate under reduced pressure at 60℃ to a density of 1.05, and set aside.

[0151] ② Take peony bark, red peony root, and perilla leaf, add 10 times the amount of raw herbs to water, reflux and extract for 1.5 hours, filter, and set aside the filtrate. Add 10 times the amount of raw herbs to the residue, reflux and extract for 1 hour, filter, combine the two extracts, and concentrate under reduced pressure at 60℃ to a density of 1.04. Combine the concentrate from step ① and continue to concentrate to a density of 1.09, and set aside.

[0152] ③ The concentrate from step ② is dried at 60°C, the dried paste is pulverized and then excipients are added to prepare granules, thus obtaining comparative composition 3.

[0153] Pharmacodynamic study of the traditional Chinese medicine composition of this invention:

[0154] Tests on the antibacterial properties of the herbal composition of this invention:

[0155] 1. Materials

[0156] Drugs and reagents

[0157] Samples: Invention Composition 1, Comparative Composition 1, Comparative Composition 2, and Comparative Composition 3 were all produced by Ping An Pharmaceutical Research Institute.

[0158] Reagent: Hydrolyzed casein agar.

[0159] Strains: 26 strains of Klebsiella pneumoniae, 26 strains of carbapenem-resistant Klebsiella pneumoniae, 26 strains of Escherichia coli, 25 strains of Pseudomonas aeruginosa, 26 strains of Acinetobacter baumannii, and 26 strains of Staphylococcus aureus isolated from the Microbiology Laboratory of Shijiazhuang Ping An Hospital in 2023.

[0160] Instrument: MIT-P multi-point inoculation instrument

[0161] method

[0162] 2.1 Preparation of Traditional Chinese Medicine Powder

[0163] Weigh 4g of each composition and place it in a 50ml sterile test tube. Add boiled sterile distilled water to the 40ml mark, which is equivalent to 100g / L of the original drug. Dissolve completely and set aside.

[0164] 2.2 Preparation of Traditional Chinese Medicine Agar Plates

[0165] Weigh 0.76g of MH agar powder and add it to eight 50mL sterile test tubes numbered 1 to 8. Add 4mL of the original drug (100g / L) to tube 1, 2mL to tube 2, and 2mL to tube 3. Serially dilute the original drug (100g / L) two-fold to prepare solutions of different concentrations. Take 2mL of each solution and serially dilute it to prepare solutions of different concentrations. Add the solution to test tubes 3-8, and add distilled water to tubes 1-8 to 20 mL. Shake well to dissolve, then autoclave. After autoclaving, pour the solution into 90 mm diameter petri dishes in a biosafety cabinet until solidified. Finally, prepare drug plates containing Chinese medicine at concentrations of 20 g / L, 10 g / L, 5 g / L, 2.5 g / L, 1.25 g / L, 0.625 g / L, 0.3125 g / L, and 0.15625 g / L.

[0166] 2.3 Preparation of bacterial suspension

[0167] The test bacteria were passaged twice on MH agar plates to ensure the purification and viability of the colonies. After the second passage at 35°C for 24 hours, the cultured colonies were taken and prepared into bacterial suspensions with sterile physiological saline at a turbidity of 0.5 McFarland.

[0168] 2.4 Cultivation and Observation

[0169] Using an MIT-P multi-point inoculation instrument, 10 μL of a prepared 0.5% McFarland turbidity bacterial suspension was inoculated onto drug plates containing different concentrations of traditional Chinese medicine and growth control plates. The plates were incubated at 35°C for 24 hours. If all growth was observed on the growth control plates and no growth was observed on the blank control plates, the minimum inhibitory concentration (MIC) of each drug plate containing traditional Chinese medicine was observed and the MIC was calculated. 50 and MIC 90 The drug concentration and cumulative inhibition percentage.

[0170] 3 Results

[0171] 3.1 Antibacterial effect of the inventive composition, Comparative Example 1, Comparative Example 2, and Comparative Example 3 on Escherichia coli

[0172] In vitro antibacterial tests were conducted on 26 strains of Escherichia coli. The results showed that the cumulative antibacterial rate against Escherichia coli increased with increasing drug concentrations of the invented composition, Comparative Example 1, Comparative Example 2, and Comparative Example 3. The cumulative antibacterial rate against Escherichia coli reached 100% when the concentrations of the invented composition, Comparative Example 1, Comparative Example 2, and Comparative Example 3 reached 5 g / L, 10 g / L, 10 g / L, and 20 g / L, respectively, indicating that the invented composition exhibited the strongest antibacterial ability. (See Table 1)

[0173] Table 1. Comparison of cumulative inhibition rates (%) of various compositions against 26 strains of Escherichia coli

[0174]

[0175] Note: *MIC 50 The concentration of traditional Chinese medicine on the drug agar plate; △MIC 90 The concentration of traditional Chinese medicine on the drug agar plate.

[0176] 3.2 Inhibitory effects of the inventive composition, Comparative Example 1, Comparative Example 2, and Comparative Example 3 on Acinetobacter baumannii

[0177] In vitro antibacterial tests were conducted on 25 strains of Acinetobacter baumannii. The results showed that the cumulative inhibition rate against Acinetobacter baumannii increased with increasing drug concentrations of the invented composition, Comparative Example 1, Comparative Example 2, and Comparative Example 3. The invented composition exhibited the strongest antibacterial activity at concentrations of 2.5 g / L, 5 g / L, 5 g / L, and 10 g / L, respectively. (See Table 2)

[0178] Table 2. Comparison of cumulative inhibition rates (%) of various compositions against 26 strains of Acinetobacter baumannii

[0179]

[0180] Note: *MIC 50 The concentration of traditional Chinese medicine on the drug agar plate; △MIC 90 The concentration of traditional Chinese medicine on the drug agar plate.

[0181] 3.3 Antibacterial effect of the inventive composition, Comparative Example 1, Comparative Example 2, and Comparative Example 3 on Klebsiella pneumoniae

[0182] In vitro antibacterial tests were conducted on 26 strains of Klebsiella pneumoniae. The results showed that the cumulative antibacterial rate against Klebsiella pneumoniae increased with the increase of the drug concentration of the invented composition, Comparative Example 1, Comparative Example 2, and Comparative Example 3. The concentrations of the invented composition, Comparative Example 1, Comparative Example 2, and Comparative Example 3 reached 5 g / L, 10 g / L, 10 g / L, and 20 g / L, respectively. The invented composition showed the strongest antibacterial ability.

[0183] (See Table 3)

[0184] Table 3. Comparison of cumulative inhibition rates (%) of various compositions against 26 strains of Klebsiella pneumoniae

[0185]

[0186] Note: *MIC 50 The concentration of traditional Chinese medicine on the drug agar plate; △MIC 90 The concentration of traditional Chinese medicine on the drug agar plate.

[0187] 3.4 Inhibitory effects of the inventive composition, Comparative Example 1, Comparative Example 2, and Comparative Example 3 on Klebsiella pneumoniae (carbapenem-resistant)

[0188] In vitro antibacterial tests were conducted on 26 strains of Klebsiella pneumoniae (carbapenem-resistant). The results showed that the cumulative antibacterial rate against Klebsiella pneumoniae (carbapenem-resistant) increased with the increase of the drug concentration of the invented composition, Comparative Example 1, Comparative Example 2, and Comparative Example 3. The concentrations of the invented composition, Comparative Example 1, Comparative Example 2, and Comparative Example 3 reached 10 g / L, 10 g / L, 10 g / L, and 20 g / L, respectively.

[0189] (See Table 4)

[0190] Table 4. Comparison of cumulative inhibition rates (%) of various compositions against 26 strains of Klebsiella pneumoniae (carbapenem-resistant).

[0191]

[0192] Note: *MIC 50 The concentration of traditional Chinese medicine on the drug agar plate; △MIC 90 The concentration of traditional Chinese medicine on the drug agar plate.

[0193] 3.5 Antibacterial effect of the inventive composition, Comparative Example 1, Comparative Example 2, and Comparative Example 3 on Staphylococcus aureus

[0194] In vitro antibacterial tests were conducted on 26 strains of Staphylococcus aureus. The results showed that the cumulative antibacterial rate against Staphylococcus aureus increased with the increase of the drug concentration of the invented composition, Comparative Example 1, Comparative Example 2, and Comparative Example 3. The concentrations of the invented composition, Comparative Example 1, Comparative Example 2, and Comparative Example 3 reached 1.25 g / L, 2.5 g / L, 2.5 g / L, and 0.625 g / L, respectively. The invented composition and other single drugs showed strong inhibitory effects against Gram-positive bacteria. (See Table 5)

[0195] Table 5. Comparison of cumulative inhibition rates (%) of various compositions against 26 strains of Staphylococcus aureus

[0196]

[0197] Note: *MIC 50 The concentration of traditional Chinese medicine on the drug agar plate; △MIC 90 The concentration of traditional Chinese medicine on the drug agar plate.

[0198] 3.6 Antibacterial effect of the inventive composition, Comparative Example 1, Comparative Example 2, and Comparative Example 3 on Pseudomonas aeruginosa

[0199] In vitro antibacterial tests were conducted on 26 strains of *Pseudomonas aeruginosa*. The results showed that the cumulative antibacterial rate against *Pseudomonas aeruginosa* increased with increasing drug concentrations of the invented composition, Comparative Example 1, Comparative Example 2, and Comparative Example 3. The concentrations of the invented composition, Comparative Example 1, Comparative Example 2, and Comparative Example 3 reached 10 g / L, 10 g / L, 10 g / L, and 20 g / L, respectively. (See Table 6)

[0200] Table 6. Comparison of cumulative inhibition rates (%) of various compositions against 25 strains of Pseudomonas aeruginosa

[0201]

[0202] Note: *MIC 50 The concentration of traditional Chinese medicine on the drug agar plate; △MIC 90 The concentration of traditional Chinese medicine on the drug agar plate.

[0203] 4. Conclusion

[0204] 1. Based on the above experiments, the inhibitory effect of the invented composition and the selected comparative composition on Gram-positive bacteria (Staphylococcus aureus) is better than that on Gram-negative bacteria (Klebsiella pneumoniae, Klebsiella pneumoniae (carbapenem-resistant), Escherichia coli, Pseudomonas aeruginosa, Acinetobacter baumannii).

[0205] 2. The antibacterial effect of the invented composition is superior to that of the comparative example.

[0206] Antipyretic test of the traditional Chinese medicine composition of this invention:

[0207] 1. Test Methods

[0208] 1.1 Adaptation period: SPF-grade male SD rats, weighing 160-180g, were acclimatized for 4 days and their rectal temperature was measured twice a day for 3 days.

[0209] 1.2 Before the experiment: Fasting was allowed for 6 hours before the experiment, but water was allowed. Rectal temperature was measured 3 times (1 time / 30min) before the experiment and the average body temperature was calculated. The group was enrolled if △T≤0.5℃ and 36.6~38.4℃.

[0210] 1.3 Modeling: 20% yeast (10mg / kg) was injected subcutaneously into the back. For the first 4 hours after modeling, the temperature was measured every 30 minutes for a total of 8 times. Patients whose body temperature rose by more than 0.8℃ were selected for the group.

[0211] 1.4 Gavage: After successful modeling, rats were randomly divided into four groups of 50 (n=10 per group). The groups included a model group, a positive control group, a low-dose administration group (0.5 times the human dose), a medium-dose administration group (human dose), and a high-dose administration group (twice the human dose). The model group received the corresponding volume of physiological saline, the positive control group received the corresponding volume of Qingkailing granules and comparative composition 1 and comparative composition 2, and the administration groups received the corresponding concentration of the composition of this invention. Administration was performed three times daily via gavage, with rectal temperature measured every 2 hours until 24 hours post-administration, for a total of 12 administrations.

[0212] 1.5 Data Processing: Experimental data were expressed as mean values. SPSS 27.0 software was used for statistical analysis of the experimental data. One-way ANOVA was used for comparisons among multiple groups. A p-value less than 0.05 was considered statistically significant.

[0213] 2. The test results are shown in Tables 7 and 8, and are attached to the instruction manual. Figure 1 .

[0214] Table 7. Results of changes in body temperature over time

[0215] 0h 2h 4h 6h 8h 10h 12h 14h 16h 18h 20h 22h 24h Model 39.4 39.3 38.9 39.2 39.0 38.8 38.8 38.7 39.0 38.9 38.8 38.8 38.7 Positive control 39.2 39.3 38.8 38.7 38.8 38.8 38.7 38.5 38.5 38.3 38.1 38.3 38.1 low dose 39.2 39.4 39.0 38.9 38.5 38.9 38.8 38.7 38.6 38.4 38.1 38.3 38.1 medium dose 39.5 39.0 38.9 38.5 38.0 38.1 38.0 38.0 38.2 38.2 38.3 38.0 37.5 High dose 39.8 39.1 39.2 38.5 38.2 37.9 38.1 38.0 38.3 38.1 38.1 37.9 37.6 Comparative Example 1 39.6 39.7 39.3 39.1 39.1 38.8 38.9 38.7 38.6 38.4 38.5 38.4 38.4 Comparative Example 2 39.3 39.6 39.3 39.2 38.6 38.9 38.8 38.6 38.6 38.4 38.3 38.3 38.3

[0216] Table 8. Results of P-value variation over time

[0217] p-value 0h 2h 4h 6h 8h 10h 12h 14h 16h 18h 20h 22h 24h Model / Positive 0.537 1.000 0.712 0.215 0.264 0.788 0.260 0.258 0.074 0.138 0.050 0.048 0.014 Model / Low 0.539 0.535 0.902 0.133 0.140 0.711 0.082 0.610 0.086 0.133 0.086 0.064 0.014 Model / Middle 0.455 0.211 1.000 0.014 0.013 0.014 0.014 0.014 0.014 0.033 0.049 0.012 0.004 Model / High 0.108 0.618 0.108 0.018 0.014 0.014 0.036 0.014 0.014 0.035 0.019 0.014 0.009 Model / Comparative Example 1 0.543 0.189 0.097 0.723 0.689 0.788 0.356 0.611 0.086 0.133 0.137 0.106 0.218 Model / Comparative Example 2 0.457 0.215 0.097 1.000 0.188 0.711 0.585 0.476 0.094 0.133 0.052 0.059 0.176 Positive / Low 0.616 0.916 0.343 0.671 0.207 0.429 0.390 0.334 0.595 0.750 0.753 0.459 0.915 Positive / Medium 0.415 0.248 0.832 0.465 0.008 0.007 0.009 0.011 0.344 0.527 0.249 0.130 0.034 Positive / High 0.214 0.459 0.059 0.401 0.012 0.007 0.012 0.011 0.596 0.596 0.833 0.141 0.008 Positive / Positive Example 1 0.495 0.154 0.047 0.201 0.258 0.908 0.696 0.334 0.595 0.747 0.111 0.325 0.269 Positive / Positive Ratio 2 0.388 0.266 0.048 0.135 0.199 0.776 0.893 0.432 0.564 0.761 0.248 0.461 0.313

[0218] 3. Experimental conclusions: Compared with the rectal temperature of the model group rats, the antipyretic effects of the positive control group and the low-dose group of the composition of the present invention were comparable, while the antipyretic effects of the medium-dose group and the high-dose group of the composition of the present invention were comparable. After 3 oral boluses and 24 hours later, the body temperature showed a significant downward trend. The experimental data show that the traditional Chinese medicine composition of the present invention can play a significant antipyretic role.

[0219] Typical clinical applications of the traditional Chinese medicine composition of this invention:

[0220] Case 1: Zhang, male, 39 years old. He visited Ping An Hospital on June 5, 2024.

[0221] The patient had a fever for two days, with a highest temperature of 39.2℃. Other symptoms included a dry, red, and swollen throat, yellow nasal discharge, headache, red and swollen tonsils, and a cough with yellow phlegm.

[0222] Blood test:

[0223]

[0224] Diagnosis: Wind-heat upper respiratory tract infection; Treatment principle: Clear heat and detoxify, expel pathogens from the exterior. The patient took 2 granules of the composition of this invention, twice a day, 20g each time. This was continued for three days. On June 8, 2024, the patient's temperature was normal, and the headache, cough, and dry throat improved. The patient continued taking the composition granules, twice a day, 10g each time. This was continued for four days. A follow-up visit on June 12, 2024, showed normal temperature, normal symptoms, and normal tonsils.

[0225] Case 2: Li Moumou, female, 42 years old, visited Ping An Hospital on March 18, 2025.

[0226] The patient presented with a fever (body temperature 38.6℃), no sweating, chills, significant sore throat and congestion, swollen tonsils with yellow exudate, nasal congestion, thirst, and no abnormalities in the lungs.

[0227]

[0228] Diagnosis: Upper respiratory tract infection, wind-heat syndrome; Treatment principle: Clear heat and detoxify, expel pathogens and release the exterior. The patient took 2 granules of the composition of this invention, twice a day, 20g each time. This was continued for 5 days. On March 23, 2025, the patient's temperature was normal, and sore throat, thirst, and nasal congestion improved. The patient continued taking the composition granules, twice a day, 10g each time. This was continued for 3 days. A follow-up visit on March 27, 2024, showed normal temperature, normal symptoms, no discomfort, and normal tonsils.

[0229] Case 3: Cai, male, 58 years old. He visited Ping An Hospital on April 17, 2025.

[0230] Fever, sweating, headache, itchy throat, nasal congestion with yellow nasal discharge, thirst. Body temperature: 38.7℃

[0231] Blood test:

[0232]

[0233] Diagnosis: Wind-heat syndrome, upper respiratory tract infection; Treatment principle: Clear heat and detoxify, expel pathogens and release the exterior. Administer 2 granules of the composition of this invention, twice daily, 20g each time. Continue for 4 days. On April 21, 2025, body temperature returned to normal, and headache, thirst, itchy throat, and nasal congestion improved. Continue taking the composition granules, twice daily, 10g each time. Continue for 3 days.

[0234] A follow-up examination on April 25, 2025 showed that the patient's temperature was normal, all symptoms had disappeared, and the patient had returned to normal.

[0235]

[0236] Case 4: Wang, male, 18 years old. He visited Ping An Hospital on August 17, 2024.

[0237] Fever, sweating, headache, itchy throat, nasal congestion with yellow nasal discharge, thirst, and cough with yellow phlegm. Body temperature: 39.2℃

[0238] Blood test:

[0239]

[0240] Diagnosis: Wind-heat syndrome, upper respiratory tract infection; Treatment principle: Clear heat and detoxify, expel pathogens and release the exterior. Administer 2 granules of the composition of this invention, twice daily, 20g each time. Continue for 3 days. On August 20, 2024, body temperature returned to normal, and symptoms such as headache, thirst, itchy throat, nasal congestion, and cough improved. Continue taking the composition granules, twice daily, 10g each time. Continue for 3 days.

[0241] On August 23, 2025, an examination revealed that the patient's temperature was normal, all symptoms had disappeared, and the patient had returned to normal.

[0242]

[0243] Case 5: Shao, female, 24 years old. She visited Ping An Hospital on May 17, 2025.

[0244] Fever, sweating, headache, nasal congestion with yellow nasal discharge, thirst, and cough with yellow phlegm. Body temperature: 38.7℃.

[0245] Enlarged tonsils and positive anti-mycoplasma pneumoniae antibody.

[0246] Blood test:

[0247]

[0248] Diagnosis: Wind-heat, upper respiratory tract infection; Treatment principle: Clear heat and detoxify, expel pathogens and release the exterior. Take 2 granules of the composition of this invention, twice a day, 20g each time. Continue for 3 days. On [Date] 2025, body temperature normalized, headache, nasal congestion, cough, and tonsillitis improved. Continue taking the composition granules, twice a day, 10g each time. Continue for 3 days.

[0249] On May 23, 2025, an examination revealed that the patient's temperature was normal, all symptoms had disappeared, and the tonsils had returned to normal.

[0250]

[0251]

[0252] Case 6: Li, male, 68 years old, visited our hospital on September 18, 2024.

[0253] Chief complaint: Cold for 2 days, fever for 1 day.

[0254] Present illness: Two days ago, the patient developed runny nose and nasal congestion after catching a cold, which was not taken seriously. Today, the patient developed a fever of 39.4℃, sore throat, cough with yellow-white sticky phlegm, nasal congestion with yellow and turbid nasal discharge, dry mouth, and general malaise. The tongue is red with a yellow coating, and the pulse is rapid.

[0255] Physical examination: No enlarged superficial lymph nodes were palpable; the pharynx was red and congested; the tonsils were not enlarged; breath sounds were coarse in both lungs, and no dry or wet rales were heard.

[0256] Laboratory tests: Complete blood count showed a white blood cell count of 7.75 × 10^9 / L, neutrophils of 91.1%, and lymphocytes of 4.5%. High-sensitivity C-reactive protein was >5 mg / L, and serum amyloid protein was 13.5 mg / L. Procalcitonin was 0.336 ng / ml. Mycoplasma pneumoniae was positive at a ratio of 1:80.

[0257] Western medicine diagnosis: Fever, upper respiratory tract infection, mycoplasma infection

[0258] Traditional Chinese Medicine Diagnosis: Wind-Heat Common Cold with Mycoplasma Infection

[0259] Prescription: 1. Composition 2 of the present invention, 3 doses in total, 1 dose daily, divided into 2 oral administrations. Lysine aspirin injection 0.9g, intramuscular injection once, immediately.

[0260] Second visit, September 21, 2024. One hour after medication, the patient sweated, with a temperature of 38.0℃. One day later, the temperature was 37.5℃, two days later it was 38℃, and three days later it was 37.5℃. Sore throat and cough significantly improved, nasal congestion and yellow nasal discharge disappeared, but dry mouth persisted. A repeat blood test showed a white blood cell count of 2.99 × 10^9 / L, neutrophils 57.9%, and lymphocytes 32.4%. Procalcitonin was 0.314 ng / mg. Mycoplasma pneumoniae was negative. Considering the recovery period from infection, medication was discontinued, and the patient was instructed to drink plenty of water.

Claims

1. The application of a traditional Chinese medicine composition in the preparation of a drug for treating acute upper respiratory tract infections caused by bacteria, characterized in that, The weight ratio of the Chinese medicinal materials is as follows: Bupleurum chinense 5-35 parts, Scutellaria baicalensis 9-50 parts, Artemisia annua 9-50 parts, Paeonia lactiflora 5-35 parts, Paeonia suffruticosa 5-35 parts, and Perilla frutescens 4-26 parts.

2. The application according to claim 1, characterized in that, The weight ratio of the Chinese medicinal materials is as follows: Bupleurum chinense 8-28 parts, Scutellaria baicalensis 12-40 parts, Artemisia annua 12-40 parts, Paeonia lactiflora 8-28 parts, Paeonia suffruticosa 8-28 parts, and Perilla frutescens 8-22 parts.

3. The application according to claim 1, characterized in that, The weight ratio of the Chinese medicinal materials is as follows: Bupleurum chinense 10-25 parts, Scutellaria baicalensis 20-35 parts, Artemisia annua 20-35 parts, Paeonia lactiflora 10-25 parts, Paeonia suffruticosa 10-25 parts, and Perilla frutescens 12-20 parts.

4. The application according to any one of claims 1 to 3, characterized in that, The traditional Chinese medicine composition may be prepared into any commonly used preparation, such preparation as tablets, capsules, granules, pills, mixtures, syrups, decoctions, powders, suppositories, gels, sprays, or injections.

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